Gastric and Colorectal Surgery Division, Department of General Surgery, Army Medical Center (Daping Hospital), Army Medical University, Chongqing, China.
Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
JAMA Surg. 2021 Dec 1;156(12):1151-1158. doi: 10.1001/jamasurg.2021.4568.
Preventing anastomotic leakage (AL) is crucial for colorectal surgery. Some studies have suggested a positive role of transanal drainage tubes (TDTs) in AL prevention after low anterior resection, but this finding is controversial.
To assess the effect of TDTs in AL prevention after laparoscopic low anterior resection for rectal cancer.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter randomized clinical trial with parallel groups (TDT vs non-TDT) was performed from February 26, 2016, to September 30, 2020. Participants included patients from 7 different hospitals in China who were undergoing laparoscopic low anterior resection with the double-stapling technique for mid-low rectal cancer; 576 patients were initially enrolled in this study, and 16 were later excluded. Ultimately, 560 patients were randomly divided between the TDT and non-TDT groups.
A silicone tube was inserted through the anus, and the tip of the tube was placed approximately 5 cm above the anastomosis under laparoscopy at the conclusion of surgery. The tube was fixed with a skin suture and connected to a drainage bag. The TDT was scheduled for removal 3 to 7 days after surgery.
The primary end point was the postoperative AL rate within 30 days.
In total, 576 patients were initially enrolled in this study; 16 of these patients were excluded. Ultimately, 560 patients were randomly divided between the TDT group (n = 280; median age, 61.5 years [IQR, 54.0-68.8 years]; 177 men [63.2%]) and the non-TDT group (n = 280; median age, 62.0 years [IQR, 52.0-69.0 years]; 169 men [60.4%]). Intention-to-treat analysis showed no significant difference between the TDT and non-TDT groups in AL rates (18 [6.4%] vs 19 [6.8%]; relative risk, 0.947; 95% CI, 0.508-1.766; P = .87) or AL grades (grade B, 14 [5.0%] and grade C, 4 [1.4%] vs grade B, 11 [3.9%] and grade C, 8 [2.9%]; P = .43). In the stratified analysis based on diverting stomas, there was no significant difference in the AL rate between the groups, regardless of whether a diverting stoma was present (without stoma, 12 [5.8%] vs 15 [7.9%], P = .41; and with stoma, 6 [8.3%] vs 4 [4.5%], P = .50). Anal pain was the most common complaint from patients in the TDT group (130 of 280, 46.4%). Accidental early TDT removal occurred in 20 patients (7.1%), and no bleeding or iatrogenic colonic perforations were detected.
The results from this randomized clinical trial indicated that TDTs may not confer any benefit for AL prevention in patients who undergo laparoscopic low anterior resection for mid-low rectal cancer without preoperative radiotherapy.
ClinicalTrials.gov Identifier: NCT02686567.
重要性：预防吻合口漏（AL）对于结直肠手术至关重要。一些研究表明，经肛门引流管（TDT）在低位前切除术后 AL 预防中具有积极作用，但这一发现存在争议。
目的：评估 TDT 在腹腔镜低位前切除治疗中低位直肠肿瘤中的 AL 预防效果。
设计、地点和参与者：这是一项多中心随机临床试验，采用平行组（TDT 与非 TDT）设计，于 2016 年 2 月 26 日至 2020 年 9 月 30 日进行。参与者来自中国 7 家不同医院，接受腹腔镜低位前切除术，双重吻合技术用于中低位直肠肿瘤；最初有 576 名患者参与本研究，后有 16 名患者被排除。最终，560 名患者被随机分为 TDT 组和非 TDT 组。
干预措施：手术结束时，通过肛门插入一根硅胶管，管尖位于吻合口上方约 5cm 处，在腹腔镜下进行。将管固定在皮肤缝线上，并连接引流袋。TDT 计划在手术后 3 至 7 天内取出。
主要结局和测量指标：主要终点是术后 30 天内的 AL 发生率。
结果：共有 576 名患者最初参与了本研究，其中 16 名患者被排除。最终，560 名患者被随机分为 TDT 组（n=280；中位年龄 61.5 岁[IQR，54.0-68.8 岁]；177 名男性[63.2%]）和非 TDT 组（n=280；中位年龄 62.0 岁[IQR，52.0-69.0 岁]；169 名男性[60.4%]）。意向治疗分析显示，TDT 组和非 TDT 组的 AL 发生率（18[6.4%]vs 19[6.8%]；相对风险，0.947；95%CI，0.508-1.766；P=0.87）或 AL 分级（B 级，14[5.0%]和 C 级，4[1.4%]vs B 级，11[3.9%]和 C 级，8[2.9%]；P=0.43）无显著差异。基于分流造口的分层分析显示，无论是否存在分流造口，两组之间的 AL 发生率均无显著差异（无造口，12[5.8%]vs 15[7.9%]，P=0.41；有造口，6[8.3%]vs 4[4.5%]，P=0.50）。TDT 组最常见的并发症是肛门疼痛（280 名患者中有 130 名，46.4%）。20 名患者（7.1%）意外早期 TDT 移除，未发现出血或医源性结肠穿孔。
结论和相关性：这项随机临床试验的结果表明，对于未接受术前放疗的中低位直肠肿瘤患者，腹腔镜低位前切除术后 TDT 可能无法预防 AL。
试验注册：ClinicalTrials.gov 标识符：NCT02686567。
